Comparison Between 5-azacytidine Treatment and 5-azacytidine Followed by Allogeneic Stem Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability
Inclusion Criteria:
- Patients with proven de novo or therapy-related MDS / CMML (WBC <13 GPT/l)according
to FAB and risk profile according to IPSS: intermediate II- risk or high-risk or
intermediate I with high-risk cytogenetic (according to IPSS, taking into account
that IPSS, however, was not validated for t- MDS), patients with secondary AML
(according to WHO) and blasts ≤ 30 % (= RAEB-t according to FAB)
- Previously untreated or maximal 1 cycle of 5-azacytidine (Vidaza®)
- Male or Female; Age 55 - 70 years
- Understand and voluntarily sign an informed consent form
- ECOG performance status of ≤ 2 at study entry
- Adequate renal and liver function: creatinine and bilirubin < 3 x the upper limit of
normal
- Sufficient cardiac function (ejection fraction > 30 %)
Exclusion Criteria:
- Blasts > 30 % in bone marrow at time of diagnosis
- Central nervous involvement
- Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
- Total bilirubin, SGPT or SGOT ≥ 3 times upper the normal level
- Left ventricular ejection fraction < 30 %
- Creatinine clearance < 30 ml/min
- DLCO < 35 % and/or receiving supplementary continuous oxygen
- Pregnant or breastfeeding female subject
- Patients with a life-expectancy of less than six months because of another
debilitating disease
- Serious psychiatric or psychological disorders
- Uncontrolled invasive fungal infection at time of registration
- Known positive for HIV or acute infectious hepatitis, type A, B or C
- Participation in another study with ongoing use of unlicensed investigational product
from 28 days before study enrollment until the end of the study